It is a study in a type of blood cancer patients. In this we will add a new medicine called Ruxolitinib in the treatment and see the results.

Phase 1

• Conditions: Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

• Registration Number: CTRI/2021/02/031251
• Lead Sponsor: Tata Research Administrative Council TRAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Newly diagnosed Ph-like B cell precursor acute lymphoblastic leukemia

2. Diagnostic bone marrow or peripheral blood sample must demonstrate a Ph-like expression profile with 1 of the following genetic lesions-

a-CRLF2 overexpression by flow cytometry( >10%)

b-CRLF2 rearrangement with fusion partners(IGH,P2RY8) or

c-JAK2 rearrangement

d-EPOR rearrangement

e-PAX5 rearrangement

f-Other JAK pathway alterations ( eg g, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) as detected by targeted RNA sequencing.

3. ECOG PS 0-3

4. Patients must have adequate organ and marrow function as defined below

-Adequate liver function (SGOT/SGPT <5 times ULN, Bilirubin <2 X ULN)

-Adequate kidney function (S. Cr < 2X ULN or Creatinine clearance > 60ml/min/1.73m2)

-Platelet count >75000/uL

5. Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

1.Patients who test positive for Ph +ve (BCR-ABL 1) / ETV6-RUNX1 / TCF3-PBX1 / MLL rearrangements / High hyperdiploidy by FISH/Conventional karyotyping

2.Seropositivity (HIV)- Patients receiving anti-retroviral therapy

3.Active replication of Hepatitis B virus / Hepatitis C virus

4.Uncontrolled comorbidities (Hypertension / Diabetes Mellitus / Seizures)

5.Pregnant patients

6.Active uncontrolled infection

7.Usage of strong CYP3A4 inhibitors within 5 half lives before first dose of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified